Saturday, December 8, 2007

FDA Black Box Warning: Anemia drugs may elevate risk of cervical cancer progression

December 6, 2007
The U.S. Food and Drug Administration in March slapped its strictest "black box" warning label on anemia drugs made by Amgen and Johnson & Johnson after study raises concerns about use by patients with cervical cancer.
Amgen Inc (AMGN) said on Thursday it is talking with U.S. regulators about updating safety warnings for anemia drugs, after data from two studies stoked concerns about their use by breast and cervical cancer patients.

Amgen also said it has been advised there will be an Oncologic Drugs Advisory Committee meeting in the first quarter of 2008 as part of the review of the entire class of oxygen-boosting erythropoiesis-stimulating agent (ESA) drugs. More >>
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